FDA approves new Gardasil vaccine protecting against five additional HPV types

By ACSH Staff — Dec 12, 2014
The Food and Drug Administration (FDA) has approved Merck s Gardasil 9, which protects against five additional strains of human papillomavirus (HPV), along with the

HPV-vaccineThe Food and Drug Administration (FDA) has approved Merck s Gardasil 9, which protects against five additional strains of human papillomavirus (HPV), along with the four strains that the original Gardasil vaccine protects against. Gardasil 9 was approved for females aged 9 to 26 and males aged 9 to 15. Those who have already been vaccinated with Gardasil can also receive Gardasil 9 as a follow-up vaccine for protection against the additional five strains.

The original Gardasil protects against HPV types 16 and 18, which are estimated to cause 70 percent of cervical cancers, along with types 6 and 11, which are known to cause genital warts. The new vaccine also protects against types 31, 33, 45, 52, and 58, which cause about 20 percent of cervical cancers. Gardasil 9 has the potential to prevent 90 percent of cervical, vulvar, vaginal, and anal cancers.

In a randomized, controlled clinical study of about 14,000 females aged 16 to 26, Gardasil 9 proved equally as effective as Gardasil in protecting against the four shared HPV types, and was 97 percent effective in provoking a protective antibody response among participants. And a study of about 13,000 people found that Gardasil 9 has minimal side effects, just as with Gardasil. The most common reported side effects were injection site pain, swelling, redness, and headaches.

All boys and girls should receive three doses of the Gardasil vaccine starting at age 11 or 12. However, despite the proven safety and effectiveness of the vaccine, not enough people are receiving them. Along with unfounded scares relating to vaccines in general, there are concerns that the HPV vaccine may lead to promiscuity in young teens. However, a recent study of 129,000 girls shows otherwise. Gardasil is more effective if received before a person becomes sexually active, and is also more effective when given to younger people. There is no reason to not receive the vaccine as recommended.

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